Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Other Name: Forteo

Placebo Comparator: Placebo

30 participants will receive placebo injection pens.

Drug: Placebo

Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Detailed Description:

Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.

This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.

Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds

Received radiation treatment to any site at any time in the past

Received chemotherapy for cancer at any time in the past

Any active cancer

Surgical repair (or attempted repair) of the fracture site in the pelvis

Use of any bone-active medications

Use of anticonvulsant therapy

Use of immunosuppressants

Any renal, gastrointestinal, liver, or metabolic bone disease

Pregnancy

High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594906